Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Midwest — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

12 daysmedian FDA review time

56 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K863677	TRADITION HIGH SPEED HANDPIECE	Midwest	1986-10-06	17
K850344	AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG	Midwest	1985-03-25	56
K792445	MW STRAIGHT ATTACHMENT	Midwest	1979-12-06	6
K792303	MW 8000-I	Midwest	1979-11-27	11
K792304	MW-8000	Midwest	1979-11-27	11
K792302	LS-100	Midwest	1979-11-27	11
K791771	ORALUMINATOR III AUTO-LIGHT	Midwest	1979-11-20	74
K791733	LIGHT-PAK	Midwest	1979-10-23	56
K790113	MIDWEST 1000	Midwest	1979-02-26	38
K781878	LIGHT, INSIDE	Midwest	1978-12-29	53
K760795	FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C.	Midwest	1976-10-20	12
K760794	FIBER OPTICS HIGH SPEED HANDPIECE	Midwest	1976-10-20	12
K760796	ORALUMINATOR III - LIGHT SOURCE FOR F.O.	Midwest	1976-10-20	12

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda